On March 25, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) issued four documents, including the new Japanese Standards of Quasi-drug Ingredients (hereafter referred to as JSQI 2021), new List of Permitted Additives in Quasi-drugs, new Pre-market Application Rules of Quasi-drugs and a Collection of FAQs. In the above four documents, the ingredient standards are revised, and the corresponding pre-market application requirements of quasi-drug products are adjusted.
The four documents took effect on March 25, 2021. A grace period of 1.5 years until September 30, 2022 was granted to allow the industry to prepare for new compliance requirements. During the period, the previous quasi-drug ingredient standards and application rules still apply.
Compared with the existing regulations, the major revisions are as follows:
1. Revisions to the JSQI
JSQI 2021 amended multiple ingredients and test methods in JSQI 2006, replacing it as a new overarching technical standard for quasi-drugs.
1. Combines the original two attached active ingredient lists into one list, and sorts them according to the kana syllabary;
2. Modifies the specifications of 1453 ingredients;
3. Deletes the ingredient Ethanol (96). After the deletion, JSQI 2021 includes 2,647 ingredients.
* Note: After deleting Ethanol (96), “Ethanol” specified in JSQI 2021 only refers to “dehydrated ethanol" and "denatured alcohol".
1. Adds two general test methods, bringing the total to 84；
2. Revises 17 test methods.
2. Revisions to the List of Permitted Additives in Quasi-Drugs
3. Clarify that the specification reference of ingredient No.1003 “Bis(Ethoxydiglycol) Cyclohexane-1,4-Dicarboxylate” shall be JSQI 2021 rather than Collections of Quasi-drugs Additives Standards;
Previous Additive List
Current Additive List (2021 Version)
Hestnut Rose Extract
Chestnut Rose Extract
Tetra (Polyoxyethylene Polyoxypropylene) Ethylene Diamine
Tetra(Polyoxyethylene/Polyoxypropylene) Ethylene Diamine
Neopentyl Glycol Di(2- Ethyl Hexanoate)
Neopentyl Glycol Di(2-Ethylhexanoate)
Di(2- Ethylhexyl)amine(Dioc tylamine)
Diglyceryl Sorbitan Tetra-2- Ethylhexanoate
Diglyceryl Sorbitan Tetra(2- Ethylhexanoate)(Digly ceryl Sorbitan Tetraoctanoate)
Mukurossi Peel Extract
Mukorossi Peel Extract
1,1'-Methylene-bis (4- isocyanatocyclohexane )･Polypropylene Glycol Copolymer
1,1'-Methylenebis(4- isocyanatocyclohexan e)･Polypropylene Glycol Copolymer
Roman Chamomile Extract
Table 1 13 Renamed Additives
3. Revisions to the Pre-Market Application Requirements of the Quasi-Drugs
Along with the revisions to the quasi-drug ingredient standards, relevant application requirements for the manufacture and sale of quasi-drugs have been modified accordingly.
For quasi-drugs newly manufactured in line with JSQI 2021, applicants are required to write “JSQI (‘外原規’ in Japanese)” in the “Ingredient and Content” column in the application form, instead of filling in the specific specification of ingredients;
For quasi-drugs that contain any of the revised ingredients in JSQI 2021 and have already obtained a manufacturing or marketing license as per the old specifications, related companies shall apply for a slight modification to change the specific specification listed in the “Ingredient and Content” column to “JSQI (‘外原規’ in Japanese)”.
Notably, the obtained manufacturing and marketing licenses will remain valid until September 30, 2022. But starting from October 1, 2022, related companies shall comply with new application rules and re-apply for new manufacturing and marketing licenses.
To facilitate enterprises’ applications for the manufacture and sale of quasi-drugs, MHLW also released a FAQs collection, which includes 29 questions relating to the marketing/manufacturing approval of quasi-drugs/cosmetics, formula and test methods, etc.
Quasi-drug and cosmetic enterprises shall pay attention to the FAQ, and conduct business in line with the latest requirements.